About this trial
Complications after surgery are common and a burden for patients and health services. Therefore it is important that clinicians improve surgical outcomes. Mitochondria are the part of the body's cells that manage energy. Research has already shown that how our body's mitochondria behave can predict who survives in intensive care patients. The investigators think this could also predict who is more likely to develop complications after surgery. Therefore a study has been designed to find out if changes in mitochondria are related to postoperative complications. This will help doctors improve how they prepare patients for surgery and potentially how they manage their treatment, and result in improving outcomes for patients after surgery.
This study will recruit patients scheduled for major abdominal surgery as part of their treatment. The investigators will take samples of breath, blood and muscle to measure changes in mitochondria from the day before surgery to 7 days postoperatively. The muscle samples will only be taken when the patient is asleep having their operation. These samples will be used to analyse mitochondria. This study will be in two phases. Phase 1 is a pilot of up to 10 patients focussed on feasibility. Following this there will be an interim data analysis. The results may allow further optimisation to reduce the patient burden, eg reduction in sampling frequency, or avoiding need for muscle biopsy. The second phase will be a full cohort study of up to 40 patients, focussed on association of mitochondrial markers with clinical outcomes, such as postoperative complications, oxygen levels, pain, confusion and length of intensive care stay.
The results of this study could improve how doctors select and prepare patients for surgery. It may also affect how doctors manage their treatment during and after operations. This could result in reducing complications and illness burden for patients after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or above.
Having elective major abdominal surgery under general anaesthesia requiring a CVC and arterial line.
Planned for a Total Intravenous Anaesthesia (TIVA) technique +/- additional regional or neuraxial anaesthesia.
Admitted >6 hours prior to planned start of surgery as part of their normal care
Disqualifiers
Currently pregnant or up to 6 weeks post-partum
Participating in an interventional research study concerning intra-operative management already
Lacks capacity to give consent to participate in the study at time of recruitment
Currently in custody
Trial population
Adults having major elective abdominal surgery
Trial design
Cohort
Prospective
Treatments tested in this trial
Observational study: no interventions
Other interventionNot applicable as observational study with no intervention
Treatment groups
Trial outcomes
Primary outcomes
Number of eligible patients screened
Number of eligible patients screened
Number of eligible patients consented
Number of eligible patients consented
Postoperative Morbidity Survey (POMS) on day 7 postoperatively
Postoperative Morbidity Survey (POMS) on day 7 postoperatively
Secondary outcomes
Difference in mitochondrial activity in platelets as measured by high resolution respirometry from start of surgery to day 7 postoperatively
Difference in mitochondrial activity in platelets as measured by high resolution respirometry from start of surgery to day 7 postoperatively
Difference in mitochondrial function as measured by 13C-KICA breath test from day before surgery to day 7 postoperatively
Difference in mitochondrial function as measured by 13C-KICA breath test from day before surgery to day 7 postoperatively
Difference in mitochondrial activity in skeletal muscle as measured by high resolution respirometry from start of surgery to day 1 postoperatively
Difference in mitochondrial activity in skeletal muscle as measured by high resolution respirometry from start of surgery to day 1 postoperatively
Length of stay in ICU/HDU environment prior to ward step-down
Length of stay in ICU/HDU environment prior to ward step-down
Sponsors and contacts
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University Hospital Southampton NHS Foundation Trust
Lead sponsor
University of Southampton
Collaborator
University of Cambridge
Collaborator
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